Catalog Number

MB221-202

Brand Name

MISO

Version/Model Number

MB221-202

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NJM

Product Code Name

Bracket, Ceramic, Orthodontic

Public Device Record Key

c814c266-d55b-4de0-ad25-33a4a7c31fac

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 11, 2017

Package DI Number

08800022212915

Quantity per Package

2

Contains DI Package

08800022212908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zipper bag